Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-833923 · 6 trials · 10 indications
The following drug-related adverse events (AEs) occurring in the first 28 days of treatment were considered dose-limiting toxicities (DLT): Grade 4 hematologic AE lasting \>7 days; ≥Grade 3 nonhematologic AE, despite medical intervention; ≥Grade 2 AE uncontrolled by medical intervention and requiring treatment interruption for \>7 days. RP2D was that dose at which ≤1 of 6 patients had a DLT in the first 4 weeks of treatment. If \<3 patients were DLT-evaluable, up to 6 additional patients entered the same dose level. Accrual to a dose level closed if 6 patients were enrolled and \<3 were DLT-evaluable. If ≥3 patients at a dose level had no DLTs when a new patient enrolled, the dose was escalated to next level. If 1 DLT was observed in \<6 patients, ≥6 patients were required; if no additional DLT was observed, the dose was escalated to the next highest level. If ≥2 DLTs were observed in \<6 patients, that level exceeded the RP2D, and the dose was deescalated to the next lowest level.
* NCI - National Cancer Institute * CTCAE - Common Terminology Criteria for Adverse Events * MTD - Maximum tolerated dose * DLT - Dose limiting toxicity
MTD - maximum tolerated dose
Use NCI CTCAE to monitor safety assessments including physical findings, laboratory tests, and radiographic assessments to establish the maximum tolerated dose and recommended Phase 2 dose range and schedule of BMS-833923
| Arm | Type | Description |
|---|---|---|
| Arm 1: BMS-833923 (XL139) | EXPERIMENTAL | - |
| Dasatinib, 100/140 mg QD | EXPERIMENTAL | Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with chronic myeloid leukemia \[CML\]-chronic phase; 140 mg for those with CML-advanced phase) |
| Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD | EXPERIMENTAL | Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg, QD |
| Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD | EXPERIMENTAL | Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) |
| Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD | EXPERIMENTAL | Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then 200 mg once daily (QD) plus dasatinib, 100 /140 mg QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) |
| All Subjects | EXPERIMENTAL | - |
| Arm 1 | EXPERIMENTAL | BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter) |
| Arm 2 | ACTIVE_COMPARATOR | BMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg) |
| Arm 3 | ACTIVE_COMPARATOR | BMS-833923 (MTD or below) Bortezomib (at or below the recommended prescribing dose) |
| BMS-833923 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-833923 (XL139) | DRUG | Capsule, Oral, 150 mg, 300 mg, or 450 mg,Once daily, Until progression of disease, unacceptable toxicity, withdrawal of subject's consent or meeting other discontinuation criteria |
| Dasatinib | DRUG | Oral tablets, 100-140 mg once daily, depending on cohort (100 mg for those with chronic myeloid leukemia \[CML\]-chronic phase; 140 mg for those with CML-advanced phase) |
| BMS-833923 | DRUG | Oral capsules, 50-200 mg, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) |
| Carboplatin | DRUG | Vial, Intravenous (IV), dose to yield 5 mg/mL - min, once every 21 days, 1 day per cycle up to 4 cycles |
| Etoposide | DRUG | Vial, Intravenous (IV), 100 mg/m²/dose, days 1, 2, \& 3 of each 21 day cycle, 3 days per cycle for up to 4 cycles |
| Cisplatin | DRUG | Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study |
| Capecitabine | DRUG | Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study |
| Lenalidomide | DRUG | Capsule, Oral, Once daily, 6 months |
| Dexamethasone | DRUG | Capsule, Oral, Once a week, 6 months |
| Bortezomib | DRUG | Powder, IV, On days 1, 4, 8, 11, 6 months |
Inclusion Criteria: * Subjects with advanced or metastatic solid tumors refractory to, or relapsed from, standard therapies or for which there is no known effective treatment * Men and woman, 20 years of age and above Exclusion Criteria: * Subjects with symptomatic brain metastasis or active brai...
BMS-833923 is an investigational small molecule being studied for the treatment of advanced cancer, small cell lung carcinoma, stomach neoplasms, leukemia, and other cancers. It has been evaluated in Phase 1 clinical trials for conditions including basal cell carcinoma and multiple myeloma. The drug is not approved and remains in clinical development.
BMS-833923 targets the Hedgehog signaling pathway, specifically the Smoothened protein. By inhibiting this pathway, the drug is being studied for its potential to treat cancers that depend on Hedgehog pathway activation. This mechanism was evaluated in early-stage clinical trials for various malignancies.
BMS-833923 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored multiple Phase 1 clinical trials of the drug in oncology indications. Bristol-Myers Squibb is responsible for the clinical development of this investigational agent.
BMS-833923 is in Phase 1 clinical development. All completed trials for the drug were Phase 1 studies, including trials in advanced cancer, small cell lung cancer, and multiple myeloma. The drug is investigational and has not received FDA approval for any indication.
BMS-833923 has been studied in four completed Phase 1 trials: NCT00670189 in advanced or metastatic cancer, NCT00884546 in multiple myeloma, NCT00927875 in extensive-stage small cell lung cancer, and NCT01413906 in solid tumors. These trials enrolled a total of 97 participants across multiple countries.
Yes, BMS-833923 is also known as XL139. The clinical trial NCT00670189, titled "A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer," confirms that XL139 is an alternative name for this drug. Both names refer to the same investigational compound.